BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PEN NEEDLE

    MDR report key: 9158035 · Received October 4, 2019

    Report

    Report Number
    2243072-2019-02213
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 16, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    NSC
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (19) USED 32G X 4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, ALSO SAID SOME OF THE NEEDLES DO NOT WORK DURING PRIMING. ALL 19 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 17 HAD BENT NON-PATIENT END (NPE) CANNULAS, ONE HAD A BROKEN NPE CANNULA, AND ONE HAD A STRAIGHT NPE CANNULA. NO EVIDENCE OF MANUFACTURING DEFECTS WAS OBSERVED ON THE PEN NEEDLES WITH EITHER BENT OR BROKEN NPE CANNULAS (SEE ATTACHED PHOTOS). THE PEN NEEDLE WITH A STRAIGHT NPE CANNULA WAS TESTED FOR FLOW USING A TEST PEN INJECTOR, AND IT WAS ABLE TO EXPEL PROPERLY. THE BENT OR BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED. SINCE ALL 19 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT OR BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. UNABLE TO PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NPE CANNULA, BROKEN NPE CANNULA). ROOT CAUSE DESCRIPTION: IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE CLOG OCCURRED WITH A UNSPECIFIED BD PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, ALSO SAID SOME OF THE NEEDLES DO NOT WORK DURING PRIMING. PROBLEM INVOLVED TWO SEPARATE BOXES OF NANO PEN NEEDLES, FIRST OCCURRENCE WAS ABOUT TWO MONTHS AGO, BOX AND SAMPLES HAVE BEEN DISCARDED, LOT AND PRODUCT NUMBERS FOR FIRST BOX ARE NOT AVAILABLE. LOT# FOR CURRENT BOX 9029775. PRODUCT # 320550. EXP 11-07-21. OCCURRENCE DATE UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948887 UNSPECIFIED BD PEN NEEDLE PEN NEEDLE NSC BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other